If genes in their natural form cannot be patented, does that mean that potentially very valuable cell types including stem cells also cannot be patented?

It’s a timely question to ask because the Supreme Court of the United States (SCOTUS) ruled yesterday that genes in their natural form cannot be patented.

Jon Rowley, very much on the ball, first asked the question yesterday on Twitter (see below) and it got me thinking more about the implications.

The SCOTUS case Association for Molecular Pathology v. Myriad Genetics drew much attention because of the major implications of a ruling either way. Here’s a nice piece on the arguments from the Stanford Law Blog for background.

SCOTUS ruled unanimously against Myriad, handing the company (and indirectly many other companies) a major, albeit expected defeat.

The focus was on Myriad’s intellectual property (IP) rights to two genes that are powerful markers for breast and ovarian cancer: BRCA1 and BRCA2. The BRACAnalysis test sold by Myriad to a quarter of a million women a year is extremely expensive at around $3,000 a pop. Analysts predict the price will go way down now, making it more accessible to women and likely saving many lives.

This is one very positive outcome of the decision, but some in the biomedical field are asking whether the ruling also might have the negative outcome of discouraging innovation. Thousands of other patents are effectively nullified and there will be a boost of competition in many areas.

Why did SCOTUS rule this way?

Justice Clarence Thomas provides the rationale in his write up:

“Myriad did not create anything,” Thomas said. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

There are thousands of patents on stem cells, many related to naturally occurring stem cells that researchers and companies did not invent.

Does this SCOTUS ruling in effect challenge the IP rights to certain kinds of stem cells?

Thomas’ particular choice of words resonates here: separating that gene from its surrounding genetic material is not an act of invention

Does that mean that separating specific stem cells from their surrounding cellular material is not an act of innovation?

A definite maybe.

As a result, could stem cell patents be invalidated too in the future?

It is quite possible.

In fact in Europe, patents on embryonic stem cell research are banned, a decision that scientists are challenging and questioning. Strangely, the rationale of the European Court for its ruling remains unclear to this day I think even to the Court itself. I think its a bad ruling.

Back here to the US and the SCOTUS ruling’s implications for the stem cell field, there is a striking paradox here for many in the stem cell field hoping to make money off of stem cell patents.

On the one hand, a major argument made by for-profit stem cell clinics is that the stem cells that they transplant into patients are naturally occurring things (even when propagated in the lab in culture) that are not more than minimally manipulated so they should not be regulated as drugs. They want the FDA off their backs.

On the other hand, in many cases the same group of folks wants patent rights to their stem cell products. They claim unique, inventive ways of producing a distinct stem cell product and they naturally want protection from competitors taking away what they perceive as their own innovation.

But you cannot have your cake and eat it too.

If your company prepares a unique stem cell product that is not simply some naturally occurring thing (as Justice Thomas indicated) it seems by definition that it is very likely to be more than minimally manipulated and hence subject to FDA regulation as a 351 drug. If your stem cell product, however, is indeed not substantially different than endogenous stem cells and you think it should be regulated as a 361 non-drug biological product, then it seems a much bigger hurdle to then also claim IP and hence patent rights to it.

There’s the rub. To be clear, I’m not against patenting stem cells, but stem cell companies that claim both minimal manipulation and patent rights may be dreaming if they think they can pull off both in the long run. Maybe they can, but the Myriad ruling raises doubts in my mind.

It will be fascinating to see how this area develops in the coming years.

On the one hand you want to encourage breeders to continue coming up with new strains of plants whatever the method, but on the other hand even plants that aren’t selectively bred can be patented, as long as it is in cultivation (not found in the wild) and if the plant can be asexually reproduced. I wonder if plant patent laws will have to be reversed with this decision.
I bet the patent laws regarding stem cells will be very complicated in the future. The same process applies with stem cells; find the cells, isolate them, and reproduce as many close to exact replicas as possible.

I guess the big difference is the source, the cells will have the genetic profile of the contributing person.
Should the person that contributes the stem cells hold the patent and should they be allowed to sell away rights to their own cells? And with stem cell therapy, if and when, the persons own cells would in theory be safer to use. The process and methods seem more important than the actual cells, unless you are talking about just research applications.

Check Diamond vs Chakrabarty. All supreme court cases build on top of previous decisions. In this case, Chakrabarty was responsible for producing genetically modified bacteria capable of digesting oil from oil spills. The basic gist is that these organisms were patentable because they do not exist in nature and are a product of human ingenuity. So plant’s with gene’s inserted into their genome that don’t occur in nature and foreseeably won’t under natural means are patent worthy.

OK, thanks for explaining that. I guess it makes sense that one should not be able to patent a chemical (drug, gene, stem cell) that already exists in nature.

But, some method by which such a chemical (drug, gene, stem cell) might be isolated/produced/artifically-propagated/injected certainly might be an innovation? I guess my question is, can you patent a method by which a product is produced even if you can’t patent the product?

Or do we think of such methods as also, ultimately, being natural… since anything that is outside nature is not possible. (Putting aside belief in the supernatural, theistic theories, and such like.) Thus, there is no innovation and no patent — not for anything?

I just checked the Regenexx Blog — and they are also talking about patents today! It is interesting that Regenexx has recently been granted 2 patents relating to their adult stem cell treatments — as far as I can understand, the patents are for devices and methods… not for the cells, as such.

Simply put, in order to evoke a similar scenario to the gene patent story, it’s not so simple to argue that stem cells are products of nature. To make this a court case, someone has to show that they are harmed by having someone have a monopoly- ownership- of stem cells. Someone has to be harmed sufficiently to bring a lawsuit- “have standing”- then the case must go through the court systems- including appeals to higher courts- before the Supreme Court will consider the case.

A good example is the Sherley v. Sebelius case- the attempt to force the NIH to stop funding hESC research in favor of somatic stem cell research. James Sherley was granted “standing”- necessary for the courts to consider the case- because he convinced the judges that he was harmed by the NIH funding hESC grants preferentially- he was unable to get funding.

So, if someone out there has a powerful case for being harmed by the stem cell patents…I’d be happy to offer my most unprofessional advice. As you know, I’m most definitely not a lawyer and speak only from my amateur point of view.

Thanks, Jeanne. I should have been clearly that I meant that if a new court challenge were to come on stem cells that this kind of precedent could be quite influential in ways that might surprise many in the stem cell field who assume their IP on stem cells is untouchable.

Paul, You may be approaching the stem cell patent question from a more limited perspective. In comparison with blood transfusion and associated cell therapy, the cells are not patented, not is the source per se. Certainly, the tubing that they flow through, the bags that the are stored in and many other things associated with a blood transfusion have been patented with the patents being upheld (I assume-have they been tested?). Using this logic, I would assume that autologous are not patentable, and probably allogeneic are not also. However, everything else once the cells leave the donor and before they are put in the recipient is probably patentable. Just like has been the case with blood transfusion. Courts traditionally go with precedent, and clearly the precedent is there with blood transfusion IP.

Richard, you make some excellent points. Even if patents on the cells themselves could not withstand challenge in court (should that come), there many other elements to the process that could be patented.

Composition of matter patents on stem cells are already worthless as they’re unenforceable. You have to prove that someone else’s stem cell is the same as yours, which is impossible. That leaves methods patents, which are enforceable but can easily be invented around unless they’re written very tightly.